GBAT+Individual(GBAT+)NCT05512221

Transdiagnostic Group Therapy (GBAT) for Autistic Adults With Personalized Therapeutics

A study testing GBAT+I, GBAT+E - Phase I, Watchful Waiting and Groups - Phase 2 and GBAT+IE in people with GBAT+Individual and GBAT+Engagement Booster, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 years
Conditions the study is for: GBAT+Individual, GBAT+Engagement Booster, GBAT+Both
What is being tested?: GBAT+I, GBAT+E - Phase I, Watchful Waiting and Groups - Phase 2 and GBAT+IE
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: 23 Sep 2022to 1 Jul 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Live in New Jersey or New York
Be 18-40 years old
Have a confirmed diagnosis of Autism Spectrum Disorders (ASD).
Have access to a device (e.g., computer with a webcam or smartphone) in order to complete online surveys and participate in videoconference sessions
WRAT Reading Comprehension grade equivalent 6th grade or higher
Receive a best-estimate diagnosis of an anxiety or mood disorder (Generalized Anxiety Disorder, Social Anxiety Disorder, Specific Phobia, Panic Disorder, Agoraphobia, Major Depressive Disorder, Unspecified Depression, Persistent Depressive Disorder).
Be interested in participating in an online telehealth treatment group to address their difficulties in the aforementioned areas
Approximately 60% of our sample will be White, Non-Hispanic; approximately 40% of our sample will be female-identifying and 40% will be male-identifying

Who cannot join

Are younger than 18 years old, or older than 40 years old
Do not have an ASD diagnosis
Have WRAT Reading Comprehension below 6th grade level
Are unable to understand English fluently
Have a principal DSM-5 disorder other than one of the above listed anxiety or depression disorders, have received a diagnosis of Intellectual Disability, schizophrenia, or bipolar disorder or demonstrate suicidal ideation or intent severe enough to require current hospitalization, or who have attempted suicide in the past 3 months.
Are currently enrolled in another behavioral therapy or psychotherapy targeting depression, anxiety or anger.
Are experiencing suicidal ideation that requires current hospitalization.
The PI's best clinical judgment that it would not be in the adult's best interest to be enrolled (e.g., due to factors that may affect their engagement or comfort in the group).

Trial locations and contacts

1 site in 1 country.

United States1 site

Rutgers University
Piscataway, New Jersey, 08854

Other trials in United States

About this study

Official title: Optimizing Engagement and Reach of a Transdiagnostic Group Therapy for Autistic Adults Through Technology and Personalized Therapeutics

The purpose of this study is to build upon an earlier study that evaluated the use of a 10-week transdiagnostic Group Behavioral Activation Therapy (GBAT), a telehealth delivered intervention, as a cost effective and accessible way to treat symptoms of anxiety and depression in autistic adults. The current study will pilot and compare relative feasibility, acceptability, and preliminary efficacy of three adapted GBAT groups and a Watchful Waiting (WW) group. The three groups include GBAT+Individual (GBAT+I; individual sessions to supplement the 10 group sessions), GBAT+Engagement Booster (GBAT+E; supplemental materials), and GBAT+Both (GBAT+IE individual sessions and supplemental materials).

Conditions: GBAT+Individual, GBAT+Engagement Booster, GBAT+Both
Being tested: GBAT+I, GBAT+E - Phase I, Watchful Waiting and Groups - Phase 2, GBAT+IE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GBAT+I, GBAT+E - Phase IOther
Phase I is the development phase, which is informed by the study team's previous pilot study and autistic advisors. It will include the development of engagement booster materials. Booster materials will be tested in 2 groups (GBAT+I and GBAT+E) of six participants each. Groups include GBAT+Individual (GBAT+I; individual sessions to supplement the 10 group sessions) and GBAT+Engagement Booster (GBAT+E; supplemental materials). The first 4-6 eligible adults recruited will participate in GBAT+I and the second 6 eligible adults recruited will participate in GBAT+E. Both groups will consist of 10 weekly 60-90-minute GBAT group sessions. Participants in the GBAT+I group will also attend 30-minute individual booster sessions, approximately between Weeks 4-5, 5-6, 6-7, and 7-8. Participants in the GBAT+E group will be asked to use booster materials in between group sessions (e.g., worksheets, goal trackers, interactive learning activities).
Watchful Waiting and Groups - Phase 2Other
Phase 2a will include a watchful waiting (WW) condition and assignment to 1 of 2 treatment conditions: GBAT+I or GBAT+E.
Participants will be assigned to WW for 10 wks. They will not receive specific therapeutic services during WW, but a member of the study team will contact them at weeks 1, 2, 4, 6, and 8 to maintain engagement and monitor for clinical deterioration.
After WW, participants will be randomly assigned to one of the treatment conditions (GBAT+I or GBAT+E). All groups will consist of 10 weekly 60-90-minute GBAT group sessions. GBAT+I participants will attend four 30-minute individual booster sessions. GBAT+E participants will be asked to use booster materials between group sessions (e.g., worksheets, goal trackers, interactive learning activities)
WW group size is based on study feasibility and availability of resources. Additional participants will also be recruited at the end of the WW period to supplement group sizes.
GBAT+IEOther
Phase 2b will include assignment to GBAT+IE, which includes components of both GBAT+I (individual sessions) and GBAT+E (supplemental materials)
All groups will consist of 10 weekly 60-90-minute GBAT group sessions. Participants in the GBAT+I group will also attend 30-minute individual booster sessions, approximately between Weeks 4-5, 5-6, 6-7, and 7-8. Participants in the GBAT+E group will be asked to use booster materials in between group sessions (e.g., worksheets, goal trackers, interactive learning activities). Participants in GBAT+IE will participate in both the individual sessions and use of booster materials.

Study groups in NCT05512221
Study group	Role	What they receive
Phase I	Experimental	GBAT+I and GBAT+E groups Receives: Other: GBAT+I, GBAT+E - Phase I
Phase 2a	Experimental	Watchful Waiting, GBAT+I, and GBAT+E groups Receives: Other: Watchful Waiting and Groups - Phase 2
Phase 2b	Experimental	GBAT+IE groups Receives: Other: GBAT+IE

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Clinical Global Impression Severity (CGIS) Scale: Independent Evaluator
The CGI-S score provides a global rating of baseline severity ranging from 1 (not at all ill) to 7 (extremely ill), while the CGI-I provides a global rating of clinical improvement ranging from 1 (Very Much Improved) to 7 (Very Much Worse). The IE will provide a baseline CGI ratings for each patient at pretreatment and posttreatment.
Measured: Change from pre-treatment to post-treatment (an average of 12 weeks)

Secondary outcomes (6)

Change in distress on Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a 9-item questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Total scores range from 0 to 27; higher scores reflect greater levels of depressive symptoms.
Measured: Change from pre-treatment to post-treatment (an average of 12 weeks)
Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a "0" (not at all) to "3"(nearly every day) scale. Total scores range from 0 to 21; higher scores reflect greater levels of anxiety.
Measured: Change from pre-treatment to post-treatment (an average of 12 weeks)
Anxiety Disorders Interview Schedule for DSM-5
The ADIS-5 is a semi-structured diagnostic interview that assesses mood and anxiety disorders. The interview focuses on clinical threshold of symptoms to inform current diagnostic presentations. Clinician Severity Rating (CSR) is rated for each diagnosis to quantify the interference of symptoms on a scale from 0 ("not at all") to 8 ("debilitating"). A score of 4 and above denotes a clinical threshold.
Measured: Change in CSR from pre-treatment to post-treatment (an average of 12 weeks)
Behavior Rating Inventory of Executive Function - Adult Form
The BRIEF is a standardized measure that captures executive functions or self-regulation in an everyday environment. The BRIEF is composed of 75 items within nine theoretically and empirically derived clinical scales that measure various aspects of executive functioning. These scales form a Behavioral Regulation Index and Metacognition Index, as well as an overall Global Executive Composite Each of the scales and indexes yields standardized scores that allow for comparison with adults of the same age and gender (T-scores with a mean of 50 and a standard deviation of 10). T-scores between 60 and 64 are considered "Mildly Elevated," while scores between 65 and 69 are considered "Potentially Clinically Elevated." T-scores above 70 are considered "Clinically Elevated" and may warrant clinical attention.
Measured: Change from pre-treatment to post-treatment (an average of 12 weeks)
Mirror Tracing Persistence Task
The MTPT is a behavioral task that evaluates persistence. The participant is asked to trace the outline of 3 stars (rated easy, medium, and difficult), one at a time. The thickness of each subsequent star's outline gets smaller, making it harder to trace. To increase distress, the cursor is programmed to operate in the opposite direction of the user's input. If the participant goes outside the outline, a buzzer sounds and puts the participant back at the start point. Prior to tracing any stars, the participant's affect is assessed using a 100-point scale (0 = none and 100 = extreme) to assess frustration, anxiety, happiness, irritability, difficulty concentrating, and physical discomfort. The participant traces the "difficult" star again, only this time they are given an option to quit. The participant's time is recorded to measure how long they persist on the final star, referred to as task persistence. Afterwards, they rate affect from 0-100 in order to assess change in affect.
Measured: Change from pre-treatment to post-treatment (an average of 12 weeks)
Distress Tolerance Test
The DTT is a behavioral task that evaluates an individual's willingness to persist at a task in spite of heightened frustration and distress. It uses the stimulus cards from the Wisconsin Card Sort Test. The DTT provides consistently negative feedback over a small number of trials (thus serving as a more "compact" distress induction) and by including the opportunity to escape after 20 trials, which provides a behavioral measure of distress tolerance.
Measured: Change from pre-treatment to post-treatment (an average of 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 20221 Jul 2024

First posted23 Aug 2022
Study start23 Sep 2022
Primary completion1 Jul 2024
Study completion1 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GBAT+IndividualStudies of the same condition, open and under way.
More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05512221
Sponsor's protocol ID: Pro2022001343
Acronym: (GBAT+)
Status last verified: Oct 2024
First submitted: 19 Aug 2022
Last updated: 29 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Engagement and Reach of a Transdiagnostic Group Therapy for Autistic Adults Through Technology and Personalized Therapeutics
ClinicalTrials.gov ID: NCT05512221
Acronym / sponsor ID: (GBAT+) / Pro2022001343
Conditions: GBAT+Individual, GBAT+Engagement Booster, GBAT+Both
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Collaborators: New Jersey Governor's Council for Medical Research and Treatment of Autism
Study start: 23 Sep 2022 (actual)
Primary completion: 1 Jul 2024 (actual)
Study completion: 1 Jul 2024 (actual)
First posted: 23 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Phase I	Experimental	Other: GBAT+I, GBAT+E - Phase IGBAT+I and GBAT+E groups
Phase 2a	Experimental	Other: Watchful Waiting and Groups - Phase 2Watchful Waiting, GBAT+I, and GBAT+E groups
Phase 2b	Experimental	Other: GBAT+IEGBAT+IE groups

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Live in New Jersey or New York
Be 18-40 years old
Have a confirmed diagnosis of Autism Spectrum Disorders (ASD).
Have access to a device (e.g., computer with a webcam or smartphone) in order to complete online surveys and participate in videoconference sessions
WRAT Reading Comprehension grade equivalent 6th grade or higher

Key exclusion criteria (8 listed)

Are younger than 18 years old, or older than 40 years old
Do not have an ASD diagnosis
Have WRAT Reading Comprehension below 6th grade level
Are unable to understand English fluently
Have a principal DSM-5 disorder other than one of the above listed anxiety or depression disorders, have received a diagnosis of Intellectual Disability, schizophrenia, or bipolar disorder or demonstrate suicidal ideation or intent severe enough to require current hospitalization, or who have attempted suicide in the past 3 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GBAT+I, GBAT+E - Phase IPhase I is the development phase, which is informed by the study team's previous pilot study and autistic advisors. It will include the development of engagement booster materials. Booster materials will be tested in 2 groups (GBAT+I and GBAT+E) of six participants each. Groups include GBAT+Individual (GBAT+I; individual sessions to supplement the 10 group sessions) and GBAT+Engagement Booster (GBAT+E; supplemental materials). The first 4-6 eligible adults recruited will participate in GBAT+I and the second 6 eligible adults recruited will participate in GBAT+E. Both groups will consist of 10 weekly 60-90-minute GBAT group sessions. Participants in the GBAT+I group will also attend 30-minute individual booster sessions, approximately between Weeks 4-5, 5-6, 6-7, and 7-8. Participants in the GBAT+E group will be asked to use booster materials in between group sessions (e.g., worksheets, goal trackers, interactive learning activities).	Other	Phase I
Watchful Waiting and Groups - Phase 2Phase 2a will include a watchful waiting (WW) condition and assignment to 1 of 2 treatment conditions: GBAT+I or GBAT+E. Participants will be assigned to WW for 10 wks. They will not receive specific therapeutic services during WW, but a member of the study team will contact them at weeks 1, 2, 4, 6, and 8 to maintain engagement and monitor for clinical deterioration. After WW, participants will be randomly assigned to one of the treatment conditions (GBAT+I or GBAT+E). All groups will consist of 10 weekly 60-90-minute GBAT group sessions. GBAT+I participants will attend four 30-minute individual booster sessions. GBAT+E participants will be asked to use booster materials between group sessions (e.g., worksheets, goal trackers, interactive learning activities) WW group size is based on study feasibility and availability of resources. Additional participants will also be recruited at the end of the WW period to supplement group sizes.	Other	Phase 2a
GBAT+IEPhase 2b will include assignment to GBAT+IE, which includes components of both GBAT+I (individual sessions) and GBAT+E (supplemental materials) All groups will consist of 10 weekly 60-90-minute GBAT group sessions. Participants in the GBAT+I group will also attend 30-minute individual booster sessions, approximately between Weeks 4-5, 5-6, 6-7, and 7-8. Participants in the GBAT+E group will be asked to use booster materials in between group sessions (e.g., worksheets, goal trackers, interactive learning activities). Participants in GBAT+IE will participate in both the individual sessions and use of booster materials.	Other	Phase 2b

Primary outcome

Change in Clinical Global Impression Severity (CGIS) Scale: Independent Evaluator
Time frame: Change from pre-treatment to post-treatment (an average of 12 weeks)
The CGI-S score provides a global rating of baseline severity ranging from 1 (not at all ill) to 7 (extremely ill), while the CGI-I provides a global rating of clinical improvement ranging from 1 (Very Much Improved) to 7 (Very Much Worse). The IE will provide a baseline CGI ratings for each patient at pretreatment and posttreatment.

6 secondary outcomes

Change in distress on Patient Health Questionnaire (PHQ-9)
Time frame: Change from pre-treatment to post-treatment (an average of 12 weeks)
Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
Time frame: Change from pre-treatment to post-treatment (an average of 12 weeks)
Anxiety Disorders Interview Schedule for DSM-5
Time frame: Change in CSR from pre-treatment to post-treatment (an average of 12 weeks)
Behavior Rating Inventory of Executive Function - Adult Form
Time frame: Change from pre-treatment to post-treatment (an average of 12 weeks)
Mirror Tracing Persistence Task
Time frame: Change from pre-treatment to post-treatment (an average of 12 weeks)
Distress Tolerance Test
Time frame: Change from pre-treatment to post-treatment (an average of 12 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vanessa Bal, PhD principal investigator

Rutgers, The State University of New Jersey

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Clinical Global Impression Severity (CGIS) Scale: Independent Evaluator (time frame: Change from pre-treatment to post-treatment (an average of 12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05512221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.